Adjustable dorsal night splint

ABSTRACT

A dorsal night splint has dynamic adjustable features that allow the patient to adjust the splint while in use to control the stretching of the plantar fascia and Achilles. A semi-rigid flexible frame is included along with a tightening strap that is anchored to the frame and by which the patient can tension the strap and adjust the structure of the frame to fit the patient&#39;s desired therapeutic or prophylactic needs.

RELATED APPLICATIONS

This application claims the benefit of U.S. patent application Ser. No.12/879,818, filed Sep. 10, 2010, which is hereby incorporated byreference herein in its entirety.

BACKGROUND

Plantar fasciitis is a painful condition that arises when the plantarfascia under a patient's arch become strained or over-stretched. Thecondition can be particularly painful after extended rest periods duringwhich the fascia stiffen and tighten. When the patient stands after thatrest period, the stiffened fascia are pressed by the force of thepatient's weight, causing further pain.

Various devices have been used to treat this condition, typicallyemploying a stiff frontal frame that fits against the front of thepatient's leg and extends in an L-shape along the patient's forefoot,being held to the patient by straps that wrap around the patient's legand foot. An example is the dorsal night splint disclosed in U.S. Pat.No. 5,776,090 to Bergman. The Bergman splint includes a frame held tothe anterior side of a patient's lower leg by straps. The frame hasstiffening ribs that permit it to hold its shape and is bent, prior tothe patient putting it on, so the frame's forefoot and foreleg portionsare held at a pre-set angle.

A variation in the Bergman splint is disclosed in U.S. PatentApplication Publication No. 2008/0208094 of Gaylord. The Gaylord splinthas an adjustable stabilizing frame that is also pre-bent to apredetermined angle, and a soft sheet of fabric with tensioning armsthat wrap around the perimeter of the leg and frame to anchor the frameto the lower leg. Another example is the Exoform® Dorsal Night Splintsold by Ossur. That splint includes a soft attachment system and a metalplate within a plastic housing. The splint is bent by the patient into apre-set L-shaped form, prior to application, with the splint retainingthis pre-set angle during use. Another variation is disclosed in U.S.Pat. No. 7,682,325 to Chan, which includes a plate that has anaccordion-like middle section and is bent into a pre-defined shape.

The frames used in the foregoing products and other similar technologiesare cumbersome and are adjustable by the patent only before the framesare applied to the leg. If the splint does not fit properly, it must beremoved before it can be adjusted, which takes more time and can lead toreduced patient compliance.

Some technologies have attempted to provide more adjustability to thedevice. One example is disclosed in U.S. Patent Application PublicationNo. 2009/0264803 of Darby et al., which includes a flexible frame with atoe strap used to elevate the patient's toes to relieve pain in theplantar fascia. That structure provides no ability for the patient toadjust the frame while positioned on the foot, and thus may not providefor a sufficiently deep stretch of the plantar fascia.

An improved system is needed to address these and other deficiencies, toachieve better fitting splints that can improve patient therapy andproduce greater patient compliance.

SUMMARY

Disclosed herein is a contoured, padded splint to be applied to the footand lower leg of a patient for treatment of plantar fasciitis andAchilles tendinitis. The splint is formed as a brace that is dynamic andadjustable by the patient, after being placed on the patient, allowingthe patient to achieve tailored flexion and optimal comfort foraddressing these conditions. Patients can sleep at night and start theirday with fascia that have been stretched and prepared for walking.

The splint generally includes a semi-rigid flexible frame configured tobe applied along the ventral (or anterior) side of the foot and lowerleg, and a tightening strap configured to allow the patient to tightenthe splint to stretch the plantar fascia.

In certain implementations, the splint includes a semi-rigid flexibleframe with a top side and an under side, the frame forming a proximalsurface that extends vertically along a user's shin and upper ankle, anda distal surface that extends along the top of the user's foot. Theproximal surface has a first receptacle, positioned centrally along theface, for engaging a tightening strap, and the distal surface has asecond receptacle for also engaging a tightening strap.

The tightening strap is an inelastic adjustable strap that engages thefirst and second receptacles and is configured to be tightened by handafter the splint is placed on the patient's lower leg. The tighteningstrap can be formed in a pulley system, with an extending end. Thepatient tightens the strap by pulling on the extending end and, as theextended end is pulled, the proximal surface and distal surface arepulled toward each other, thereby stretching the user's plantar fasciaunder the arch and heel. The proximal and distal surfaces of the frameare then anchored in a fixed position relative to each other by securingthe tightening strap.

A soft housing is also included to fit under the user's foot and attachthe frame to the user's lower leg. In certain embodiments, the softhousing is made of laminate, Neoprene or other fabric.

In certain implementations, the splint includes a forefoot support padpositioned between the user's toes and the soft housing. The forefootsupport pad is configured to fit comfortably to the patient's toes andthe ball of the foot. In certain examples, the forefoot support padincludes a distal lift area that fits under the toes, a proximal supportarea that fits behind the ball of the patient's foot, and a troughbetween the support areas which holds the ball of the patient's foot.

In certain examples, an adjustable toe strap is included to attach tothe soft housing and extend around the distal end of the patient's toesand connect with the distal surface of the frame. In certain examples,the toe strap is configured with an attachment mechanism, such as aD-ring, that allows it to inter-fit with the attachment strap and besecured to the frame by operation and tightening of the attachmentstrap. In certain examples, a liner or support pad is also used to fitbetween the frame and the patient's leg, thereby providing comfort andenhanced wearability. In certain implementations, the support pad ismade of open cell foam to provide air circulation and moisture wicking.

The frame of the splint may be configured with receptacles, includingslots, and hinge mechanisms that receive tightening straps and serve asanchoring points for securing the splint to the patient. In certainexamples, the frame includes one or more hinged flaps that extend alonglateral and medial edges of the frame, and each flap has a through-holeor slot that receives tightening straps to help adjust and fit thesplint to the patient. The frame may also include tapered or cut-outsections that allow the frame to contour to particular anatomicallocations on the patient, such as the ankle region.

Various alternative embodiments and sub-features are also disclosedherein with respect to the splint, as will become apparent in thefollowing description.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary implementations of the dorsal night splint are described andshown below in the following figures, where like numerals represent likestructures in repeating figures.

FIG. 1 depicts an exemplary embodiment of a dorsal night splint, appliedto a patient's lower leg.

FIGS. 2A and 2B show top and under side views, respectively, of theframe used in an exemplary dorsal night splint according to thedisclosure herein.

FIGS. 3A and 3B show underside views of the frame of FIGS. 2A and 2B,with an attachment mechanism.

FIGS. 4A and 4B show additional implementations and embodiments of theframe and strapping systems of FIG. 1.

FIG. 5 shows an implementation of a dorsal night splint having a softhousing and brace componentry in an unattached configuration.

FIG. 6 depicts the dorsal night splint of FIG. 5 in an attachedconfiguration.

FIG. 7 depicts a support pad being used in a dorsal night splint.

FIGS. 8A and 8B depict examples of the support pad of FIG. 7 in a dorsalnight splint.

DETAILED DESCRIPTION

Disclosed herein is a contoured, padded splint to be applied to thelower leg of a patient for treatment of plantar fasciitis and Achillestendinitis. The splint is dynamic and adjustable by the patient,allowing the patient to achieve tailored flexion and optimal comfort foraddressing these conditions. Wearing the splint allows patients to sleepcomfortably at night and start their day on a better foot.

The splint includes a semi-rigid flexible frame configured to fit alongthe ventral (anterior) side of the foot and lower leg, and an inelastictightening strap configured to allow the patient to tighten the splintand stretch the plantar fascia.

An exemplary embodiment of the splint is shown in FIG. 1 as the splint100. The splint 100 has a flexible, semi-rigid frame 102 that is appliedto a user's lower leg by a flexible soft housing 114 that wraps aroundthe dorsal (posterior) side of the foot and anchors the frame 102 to theleg. As shown, the frame 102 fits over a support pad 140 that cushionsthe frame 102 against the leg. The pad fits between the patient and theframe 102 and cushions the patient's leg with respect to the frame 102.In certain implementations, the support pad 140 is made of a layer ofopen-cell foam affixed to a closed-cell foam liner, the closed cell foamliner having hook-and-loop material that attaches to complementaryhook-and-loop material on the under side of the frame 102. The open cellfoam of the pad 140 provides for air circulation to cool the patient andmoderate moisture within the brace, thus improving its usability fornighttime wear. A flexible strap 120 is also included, extending fromthe distal surface 106, in front of the patient's foot, over the distaltip of the pad 140 and connecting to the splint on the bottom side ofthe soft housing 114.

The frame 102 includes a proximal surface 104 that fits along the user'slower leg, a distal surface 106 that fits along the user's foot, and abend 105 that spans between the proximal and distal surfaces. Atightening strap 108 with pull tab 109 extends between the proximalsurface 104 and the distal surface 106 of the frame 102, allowing thepatient to adjust and tighten the splint by hand while it is applied tothe patient's leg, as explained more fully below. The frame 102 isconstructed of a semi-rigid but flexible material, which can bend uponthe application of a force applied by a tensioning strap but is alsosturdy enough to resist that force in a controlled manner, unlike acloth or sock which would simply fold or stretch when the force isapplied. In certain implementations, the frame is made of flexiblepolypropylene by injection molding, but lightweight aluminum or othersemi-rigid materials could also be used.

FIGS. 2A and 2B illustrate the frame 102 and its cross strap 108 infurther detail. As shown in FIGS. 2A and 2B, the frame 102 has aplurality of hinged flaps 121 and 125 and slots 116 and 118 positionedalong respective edges of the frame. In certain embodiments, the hingedflaps and slots are co-molded with the frame and integral to thepolypropylene material of the frame. As shown, the flap 121 is connectedto the edge 131 of the frame by a thin piece of plastic 123, whichbecause of its thin cross section can bend as a hinge point. Similarly,the flap 125 is connected to the edge 135 of the frame by a thin plastichinge section 127. The edge 135 forms a cut-out or narrowing section ofthe frame, providing the carve-out section 133 of bend area 105 thattapers in toward the center of the frame, for a more particular andcomfortable fit around the user's ankle. The slot 113 is formed alongthe edge of the distal surface of the frame by a raised ridge 175 thatextends above the distal surface of the frame. Similar structures arealso included on the opposite side of the splint. As explained below,the hinged flaps and slots receive straps from the soft housing 114 tohelp secure the frame 102 to the leg.

The frame also has receptacles 110 and 112, located centrally across thetop side of the frame, for engaging the tightening strap 108. Thetightening strap 108 is made of nylon or other inelastic material and isfolded into a plurality of sections that loop through the receptaclesand fold back upon each other, forming a pulley and anchoring system. Asshown in FIG. 1, the strap 108 extends directly between the proximalsurface 104 and the distal surface 106, bypassing the bend 105, whichcreates a large space 153 between the strap 108 and the bend 105 alongthe upper surface 102 a of the frame. The spacing and anchoring, and theinelasticity of the strap, allow the patient to secure and tighten theframe by hand while wearing it, thereby adjusting the tension on theplantar fascia and Achilles.

More particularly, as shown in FIGS. 3A-3B and 4A-4B, the strap 108 hasa top section 108 a, a bottom section 108 b, a distal end section 108 c,a proximal end section 108 d and a section 108 e. The receptacle 112includes three slots 112 a, 112 b, and 112 c, and the receptacle 110includes slots 110 a and 110 b. The proximal end section 108 d of thestrap 108 is riveted to the under side 102 b of the distal surface 106of the frame 102, creating an anchor point at the rivet 114, and thestrap 108 extends through slot 112 a at the bottom section 108 b. Thebottom section 108 b extends above the exterior of the frame 102 towardthe proximal surface of the frame 102, spaced above the top side 102 a(and the bend 105), and protrudes into the slot 110 b, forming a foldthat loops underneath the proximal surface 104 and then back through theslot 110 a. The top portion 108 a of the strap extends back across theexterior face of the frame, toward the distal surface of the frame, andinto the slot 112 b. After passing through slot 112 b, the section 108 eof the strap 108 forms another fold that passes under the under side 102b of the distal portion of the frame 102 and extends through the slot112 c. After passing through the slot 112 c, the strap section 108 cextends out the front of the brace where it is received by the patientfor tightening. As shown, the pull tab 109 is positioned on one side (ormay surround) the distal tip of the strap section 108 c.

To tighten the brace, the patient pulls the tab 109 toward him orherself, which pulls the section 108 c and in turn pulls the section 108a and then the section 108 b. Because of the anchoring of the section108 d against the rivet 114, pulling the strap tightens and lifts thedistal surface 106 toward the proximal surface 104, as illustrated bythe directional arrow 151 of FIG. 1, thereby lifting the patient'sforefoot toward the shin to stretch the fascia tissue on the undersideof the foot. The distal surface is drawn toward the proximal surfaceuntil the two surfaces reach a desired relative position, whereupon thepatent attaches the pull tab 109 to the remainder of the strap 108(e.g., by Velcro or other hook-and-loop attachment) to anchor the strapand the two surfaces in that position. As shown, the tab 109 is securedto the surface 108 a of the strap at a position located between thereceptacles 110 and 112 (e.g., a mid-way point), which centers the forceapplied by the distal and proximal surfaces of the frame between the tworeceptacles. The two surfaces are thereby anchored in the relativeposition, having a fixed angle between them which angle can be adjustedby the user while wearing the splint. The tensioning strap 108 thusallows the patient to easily adjust the structure of the frame itself toa desired position and tension while in use. The user can thereby selectand apply a constant stretching force to the plantar fascia.

Also shown in FIGS. 3A and 3B, on the underside 102 b of the frame 102,sections 150, 152, 154, 156, and 158 contain Velcro or otherhook-and-loop attachment mechanisms and are included to connect thesupport pad 140 (which has complementary hook-and-loop materials on itssurface) to the frame 102.

FIG. 4A further illustrates the forefoot strap 120. The strap 120further lifts and supports the plantar fascia and the Achilles tendon.The strap 120 is configured with a D-ring 122 on an end thereof. TheD-ring receives the distal section 108 c of the strap 108. Thus, whenthe strap 108 is tightened by pulling the tab 109, the D-ring 122 ispulled tight against the splint by the strap 108, thereby anchoring thestrap 120 to the strap 108. The distal end 160 of the strap 120 isanchored by Velcro or another attachment mechanism to the bottom side ofthe soft housing 114. When so anchored, the strap 120 extends from thebottom of the housing 114 across the front of the support pad 140,arcing over the patient's toes and anchoring to the top side of the softhousing 114.

As noted above, the frame 102 is secured to the patient's leg by theflexible housing 114. The flexible housing 114 is preferably made oflaminate material including 0.050″ thick open-cell foam sandwichedbetween two layers of UBL (unbroken loop, a material that mates withhook material, e.g., from Velcro), the combination of which forms asoft, comfortable, breathable wrap that is easily attachable anddetachable by the user. Other soft materials, such as Neoprene, may alsobe used. In use, the flexible housing 114 fits around the dorsal side ofthe patient's foot and lower leg. In the illustrated implementations,the housing 114 has attachment straps and hook-and-loop attachmentsurfaces for securing it to the frame 102. As shown more particularly inFIG. 5, the housing 114 includes the straps 115, 117, and 119, eachstrap having an analogous strap on the opposite side of the housing 114.As shown, the strap 115 has an end 115 a and an end 115 b. The end 115 afits within the slot 116 a of the hinged flap 121. The strap end 115 bfits within the corresponding slot 116 b on the opposite side of theframe. Similarly, the strap 117 a fits within the slot 118 a of thehinged flap 125 a, and the strap 117 b fits within the slot 118 b of thehinged flap 125 b. The strap 119 fits within the slot 113, which has araised ridge 170 a that rises above the distal surface of the frame. Theraised ridge 170 a forms a tunnel through which the strap extension 119a can pass. A similar structure is used on the opposite side of thesplint 100 for the receipt and tightening of the strap 119 b. In use,the straps are inserted within their respective slots, from the underside 102 b of the brace, and pulled up through the slots and folded andsecured back upon themselves with the hook-and-loop connection. Whenfully assembled, the straps are fitted with respect to the frame asshown in FIG. 6.

As shown in FIGS. 7 and 8A-8B, a forefoot pad 130 may also be used withthe splint to help provide support for the patient's toes and the ballof the foot, further enhancing support for the plantar fascia. The footpad 130 is placed underneath the foot and within the inner surface ofthe housing 114 and is releasably connected to the housing 114 byhook-and-loop material or another releasable attachment mechanism. Asshown, the forefoot pad 130 includes an upper section 132, a lowersection 134, and a trough 136. The upper section 132 is positioned tofit underneath the patient's toes, the lower section 134 is positionedto fit behind the ball of the patient's foot and support the upper arch,and the trough 136 is positioned to receive the ball of the foot. Asshown in FIG. 8B, the upper section 132 has a thickness 135 that isgreater than the thickness 133 of the lower section 134. The uppersection 132 thus provides a distal lifting area, and is configured tolift the patient's toes higher than the upper arch would be lifted bythe lower section 134. This distal lifting area works in concert withthe toe strap 120, as well as the cross strap 108, to support theplantar fascia. The lower section 134 provides a proximal support areafor the region of the patient's foot immediately behind the ball.

FIG. 7 shows the assembled and attached splint structure of FIG. 6having the strap 119 released and opened, and showing the insertion ofthe forefoot pad 130. As shown and described above, the forefoot pad 130fits underneath the patient's foot, and supports the toes and ball ofthe foot as described above. After insertion of the pad, the strap 119is then connected to the frame as described above to secure the frame(and the forefoot pad 130) to the patient.

It is to be understood that the forgoing description is merelyillustrative. While several embodiments have been provided in thepresent disclosure, it should be understood that the disclosed systems,components, and methods may be embodied in many other specific forms,variations and modifications without departing from the scope of thepresent disclosure.

The disclosed features may be implemented in sub-combinations with oneor more other features described herein, and the various featuresdescribed or illustrated above may be combined or integrated in othersystems or certain features may be omitted, or not implemented. Avariety of orthopedic bracing products may be implemented based on thedisclosure and still fall within the scope.

Examples of changes, substitutions, and alterations could be made by oneof skill in the art without departing from the scope of the informationdisclosed herein. Certain particular aspects, advantages, andmodifications are within the scope of the following claims. Allreferences cited herein are incorporated by reference in their entiretyand made part of this application.

1-24. (canceled)
 25. A splint for stretching a wearer's plantar fascia,comprising: a frame having: a first portion that extends along awearer's lower leg; a second portion that extends along a wearer's foot;and a bend portion that spans between the first and second portions; anda tightening strap that extends between the first and second portions,wherein adjustment of the tightening strap stretches the wearer'splantar fascia.
 26. The splint of claim 25, wherein: the first portionextends away from the bend portion to a first end; the second portionextends away from the bend portion to a second end; and adjustment ofthe tightening strap changes a distance between the first and secondends.
 27. The splint of claim 26, wherein adjustment of the tighteningstrap flexes or relaxes the bend portion.
 28. The splint of claim 27,wherein the tightening strap has a first strap end that anchors to oneof the first and second portions and a second strap end that is pulledby the user to tighten the splint.
 29. The splint of claim 28, furthercomprising a receptacle positioned on one of the first and secondportions of the frame, wherein the strap loops through the receptacle.30. The splint of claim 29, wherein: the receptacle is positioned on thesecond portion of the frame; and the tightening strap comprises: a firstsection that extends from the first portion of the frame; a secondsection that loops through receptacle; and a third section that extendstoward the first portion of the frame and secures to the first section.31. The splint of claim 30, wherein the first section of the tighteningstrap is riveted to the first portion of the frame.
 32. The splint ofclaim 25, further comprising a pull tab at a distal end of thetightening strap.
 33. The splint of claim 32, wherein the pull tab issecured to the tightening strap to maintain stretching of the wearer'splantar fascia.
 34. The splint of claim 33, further comprising a hookand loop mechanism that secures the pull tab to the tightening strap.35. The splint of claim 33, wherein the pull tab is secured to thetightening strap at a point that is midway between the first and secondportions of the frame.
 36. The splint of claim 25, further comprising aforefoot support pad attached to the second portion of the frame. 37.The splint of claim 36, wherein the forefoot support pad is releasablyattached to the second portion of the frame by a hook and loopmechanism.
 38. The splint of claim 36, wherein the forefoot support padincludes a distal lift area that fits under the user's toes and aproximal support area that fits behind the ball of the user's foot,wherein the distal lift area is thicker than the proximal support area.39. The splint of claim 38, wherein the forefoot support pad includes atrough spaced between the distal lift area and the proximal support areafor receiving the ball of the user's foot.
 40. The splint of claim 25,wherein each of the first portion, second portion, and bend portion ofthe frame are made of a semi-rigid material that bends upon applicationof a force by the tightening strap and sturdy enough to resist the forcein a controlled manner.
 41. A method of applying a splint to stretch awearer's plantar fascia, comprising: securing a first portion of thesplint to the wearer's lower leg with a first attaching strap; securinga second portion of the splint to the wearer's lower leg with a secondattaching strap; and adjusting a tightening strap, wherein adjustment ofthe tightening strap flexes a bend portion of the splint that spansbetween the first and second portions and stretches the wearer's plantarfascia.
 42. The method of claim 41, wherein adjusting the tighteningstrap comprises pulling a distal end of the tightening strap andsecuring the distal end to the tightening strap.
 43. The method of claim42, wherein the distal end is secured to the tightening strap byengaging a hook and loop mechanism.
 44. The method of claim 42, whereinpulling the distal end comprises pulling the distal end towards thefirst portion of the splint.